The FDA has cleared Bayer and Johnson & Johnson’s anticoagulant Xarelto for use in hospitalised, acutely ill medical patients at risk of serious blood clots. The approval came as a result of data from the MAGELLAN and MARINER trials of Xarelto (rivaroxaban), which showed that the drug could be safely used to prevent venous thromboembolism
FDA has given Breakthrough Therapy Designation to Bayer’s PI3K inhibitor Copanlisib for marginal zone lymphoma (MZL) patients who have received two prior therapies. MZL is an indolent form of non-Hodgkin’s Lymphoma (iNHL) and accounts for approximately 10% of all non-Hodgkin’s Lymphoma cases in the US. The designation was based on data from a MZL subgroup
Bayer’s Regorafenib has received a final approval from NICE for use by the NHS to treat advanced liver cancer. Regorafenib is recommended as an option for treating advanced unresectable hepatocellular carcinoma in adults who have had Sorafenib, however they can only receive the treatment if they have Child–Pugh grade A liver impairment and an Eastern
Loxo Oncology and Bayer have stated that they should be hearing from the FDA about their tumour biomarker-targeted cancer drug larotrectinib by 26 November, after picking up a priority review by the US regulator. The TRK inhibitor Larotrectinib is being reviewed by the US regulator for adult and paediatric patients with locally advanced or metastatic
NICE has recommend that three separate treatments for thyroid cancer should be made available for use on the NHS: Ipsen’s Cometriq, Bayer’s Nexavar, and Eisai’s Lenvima. The former two were previously only available via the Cancer Drugs Fund (CDF), and Eisai’s finally gains approval after delays of over two years. Eisai’s tyrosine kinase inhibitor was
NICE have issued updated guidelines for the treatment of wet age-related macular degeneration, by continuing to back use of both Bayer’s Eylea and Novartis’ Lucentis. According to the guidelines issued by NICE, the intravitreal anti-vascular endothelial growth factor (VEGF) treatment should be recommended for late AMD (wet active) for eyes with visual acuity within a
NICE issue first fast-track guidance, recommending Bayer’s drug Eylea for choroidal neovascularisation (CNV). As a result, the drug will be made available to patients in England and Wales approximately five months earlier than if it had gone through the standard NICE procedure. It is believed that there are approximately 3,200 people in England living with
Bayer announces that its investigational blood cancer treatment, copanlisib, has been awarded priority review designation from the FDA, thereby meaning the regulator pledges to review the product within a six-month timeframe. The blood cancer drug is an intravenous pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor with predominant inhibitory activity against PI3K-α and PI3K-δ isoforms. It is indicated
The National Institute for Health and Care Excellence (NICE) in a provisional guidance said Bayer’s Eylea (aflibercept) is not recommended as a first line treatment. However, it is recommended only if laser photocoagulation had not been positive or if laser photocoagulation is not suitable due to extent of macular haemorrhage.
Bayer has received approval from the European Commission for its haemophilia A drug, Kovaltry (octocog alfa) in patients of all age groups. Thereby allowing it to market the product in all 28 EU member states.